Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 6:11 PM
Study NCT ID:
NCT03844035
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impacts of Oral Irrigation in Patients With Periimplant Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. After baseline examinations \\[Silness-Löe plaque index(PI), Löe-Silness gingival index(GI), probing pocket depth(PPD), clinical attachment level(CAL), bleeding on probing(BOP)\\], initial periodontal therapy was completed using full-mouth disinfection method. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-15', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-15', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periimplant crevicular fluid level of IL-1β as a marker of gingival inflammation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Elevated levels of IL-1β in periimplant crevicular fluid have been associated with the destructive changes that occur in the inflamed human gingiva'}, {'measure': 'Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'TGF-β1 plays a role in the development and progression of periodontal diseases.'}, {'measure': 'Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Higher levels of t-PA in periimplant crevicular fluid have been associated with gingivitis and periodontitis.'}, {'measure': 'Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Higher levels of PAI-1 may be associated with progression of periodontitis'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periimplant mucositis'], 'conditions': ['Peri-implant Mucositis']}, 'referencesModule': {'references': [{'pmid': '34251534', 'type': 'DERIVED', 'citation': 'Tutuncuoglu S, Cetinkaya BO, Pamuk F, Avci B, Keles GC, Kurt-Bayrakdar S, Lutfioglu M. Clinical and biochemical evaluation of oral irrigation in patients with peri-implant mucositis: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):659-671. doi: 10.1007/s00784-021-04044-x. Epub 2021 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'The present study aimed to investigate clinically the cleaning effectiveness of different treatment modalities, that is, oral irrigator or interdental brush usage addition to routine brushing and examine TGF-β1, IL-1β, t-PA, and PAI-1 levels in periimplant crevicular fluid of patients with periimplant mucositis. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who use implant-supported protheses.', 'detailedDescription': 'Detailed Description: Our aim was to evaluate efficacy of a manual tooth-brush with either interdental brush or oral irrigator in treatment of periimplant mucositis.\n\nMaterial and Method: Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. After baseline examinations \\[Silness-Löe plaque index(PI), Löe-Silness gingival index(GI), probing pocket depth(PPD), clinical attachment level(CAL), bleeding on probing(BOP)\\], initial periodontal therapy was completed using full-mouth disinfection method. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.\n\nThe hypothesis of our study is that oral irrigators may be effective in oral care of individuals using an implant-supported prosthesis because of the ease of use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject with no systemic diseases that affect oral tissues and the nature of plaque,\n* with no professional cleaning for at least six months prior to baseline examination,\n* with one or more implants (Straumann, Waldenburg, Switzerland) functioning at least 24 months before the start of the study\n* having implants with BOP in at least two of the six regions\n* The people who agreed to refrain from the use of any nonstudy dental device or oral care product for the study duration were included in the study\n\nExclusion Criteria:\n\nExclusion criteria\n\n* subjects not cooperative,\n* having disease associated with bacteremia,\n* taking medication influencing gingival health (eg. dilantin, calcium channel blockers, cyclosporine, anticoagulants),\n* using long-term antibiotic and anti-inflammatory agents,\n* smokers and\n* women who were pregnant and in lactation period'}, 'identificationModule': {'nctId': 'NCT03844035', 'briefTitle': 'Impacts of Oral Irrigation in Patients With Periimplant Mucositis', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Clinical and Biochemical Evaluation of Oral Irrigation in Patients With Periimplant Mucositis', 'orgStudyIdInfo': {'id': 'B.30.2.ODM.0.20.08/1034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral irrigator group', 'description': "Fifteen patients using toothbrush and oral irrigator(oxytet oral irrigatör).All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual).PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites.Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.", 'interventionNames': ['Diagnostic Test: Periimplant crevicular fluid (PICF) collection']}, {'type': 'EXPERIMENTAL', 'label': 'Interdental brush group', 'description': "Fifteen patients using toothbrush and interdental brush.All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.", 'interventionNames': ['Diagnostic Test: Periimplant crevicular fluid (PICF) collection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': "Fifteen patients using only toothbrush.All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.", 'interventionNames': ['Diagnostic Test: Periimplant crevicular fluid (PICF) collection']}], 'interventions': [{'name': 'Periimplant crevicular fluid (PICF) collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Prior to PICF sampling, supragingival plaque was removed by sterile curets and, after air drying, the surfaces were isolated by cotton rolls. Filter paper strips (periopaper, proflow Inc., Amityville, New York, USA) were placed in sulcus for 30s. Care was taken not to avoid mechanical trauma and strips contaminated with blood or saliva were discarded. The absorbed PICF volume was estimated by a calibrated instrument (periotron 8000, proflow Inc., Amityville, NY, USA). Then, the strips were sealed into sterile tubes before freezing at -80⁰C. The readings were converted to an actual volume (µl) by reference to the standard curve.', 'armGroupLabels': ['Control group', 'Interdental brush group', 'Oral irrigator group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Burcu OZKAN CETINKAYA, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology,'}, {'name': 'Sema TUTUNCUOGLU, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsun Oral and Dental Health Hospital, Samsun, Turkey'}, {'name': 'Ferda PAMUK, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Beykent University, Faculty of Dentistry, Department of Periodontology'}, {'name': 'Bahattin AVCI, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuzmayis University, Faculty of Medicine Department of Biochemistry'}, {'name': 'Gonca Cayir KELES, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Okan University, Faculty of Dentistry, Department of Periodontology'}, {'name': 'Muge LUTFIOGLU, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology'}, {'name': 'Şevki GULER, Assist.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Izzet Baysal University, Faculty of Dentistry, Department of Periodontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Periodontology', 'investigatorFullName': 'Burcu Ozkan Cetinkaya', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}